Acute Outcome of Stent Therapy for Coarctation of the Aorta: Results of the Coarctation of the Aorta Stent Trial

ObjectivesThe coarctation of the aorta stent trial (COAST) is a pivotal trial of the NuMED Cheatham Platinum Stent((R)) for treatment of coarctation of the aorta (CoA). BackgroundCoA is a congenital obstruction to flow through the aorta. Stents have been used since the 1990s to treat CoA; none have been approved by the Food and Drug Administration for this indication. MethodsIn a prospective, multicenter study 105 patients received stents for treatment of CoA. Data was collected in the catheterization laboratory, on discharge and at 1-month postprocedure. ResultsOf 105 patients, 69% were male; 57% had native CoA. Noninvasive, baseline systolic blood pressure (SBP) showed upper extremity (UE) SBP to be 140 16 mm Hg and UE to lower extremity (LE) SBP difference 29 +/- 17 mm Hg. At catheterization, baseline ratio of minimum CoA diameter to diameter of descending aorta (CoA:DAo) was 0.46 +/- 0.16. Implants (104/105) were successful with one stent migration. There were no deaths or serious complications. Paradoxical hypertension occurred in 6%. Four percent of patients experienced somewhat serious adverse events related to the procedure. All patients achieved relief of ascending aorta to Dao pressure gradient: mean = 2.0 +/- 4.0 mm Hg (P < 0.001). The CoA:DAo increased to 0.84 +/- 0.18. At 1-month, UE SBP was 120 +/- 12 mm Hg, UE to LE SBP difference = -1 +/- 12 mm Hg. Ninety-nine percent of patients had UE to LE SBP difference <20 mm Hg. ConclusionsStenting of CoA, using the NuMED Cheatham Platinum Stent, is acutely safe and effective for treatment of CoA. (c) 2013 Wiley Periodicals, Inc.